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Regulatory Affair Medical Devices Consultant

Regulatory Affair Medical Devices Consultant

  • Location

    Hertfordshire, England

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Denise Saab

  • Contact email:

    Denise.Saab@volt.eu.com

  • Job ref:

    75280-PHARM-DEB_1571324315

  • Published:

    8 months ago

  • Expiry date:

    2019-11-16

  • Start date:

    ASAP

The consultant will be accountable to the company activities in regulatory affairs relating to in-vitro medical devices/diagnostics (IVDs) .

ROLE AND RESPONSIBILITIES

  • Provide strategic direction and operational regulatory support as the Functional Lead on the project teams and other groups within company as required.

  • Manages submission activities for a variety of device regulatory approvals including CE marks, Q-submissions (including briefing books), US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.

  • Provides support to marketed products, labelling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to EU, US and international regulatory requirements.

  • Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations and maintenance of international regulatory approvals to market devices.

  • Review, interpret, and report on product specific regulatory issues including evolving regulatory intelligence that may have an impact on the business units, the corporation, or the customer to the Regulatory leadership and concerned Regulatory Gene Therapy 

Product Leads.

  • Lead and manage interactions with Regulatory Authorities/Stakeholders as appropriate (e.g. CDRH, CLIA, Notified Bodies, etc.).

  • Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.

  • May perform other duties as required or assigned.


QUALIFICATION, EDUCATION AND EXPERIENCE REQUIREMENTS

  • Bachelor degree in science, engineering, or related technical field; advanced degree preferred.

  • Minimum 5 years experience in regulatory IVD preferably (EU + US )

  • Experience with regulatory submissions including CE-marking, clinical trial notifications, IDE, 510(k), and PMA submissions.

  • Awareness of IND, NDA/BLA, CTA and MAA as a minimum.

  • Experience in diagnostics or biomarker development with emphasis on gene therapy/oncology a plus

  • A demonstrated ability to create and drive an effective regulatory strategy to support commercialization.

  • Experience of planning and leading meetings with the key regulatory stakeholders e.g. FDA, Notified Bodies and CLIA.

  • A track record of ability to handle critical issue effectively with demonstrated creativity in solving regulatory issues


PREFERRED SKILLS

  • Tolerant of uncertainty

  • The ability to plan, coordinate and lead activities simultaneously on multiple projects

  • The ability to work in a matrix interact effectively with all levels of seniority both internally and externally.

  • Excellent leadership qualities with a track record of building and successfully leading regulatory teams

  • The ability to be proactive and drive themselves towards goals

  • Strong organisational and strategic skills

  • Well established negotiating and influencing skills